Telephone Assessment and Skill-Building Intervention for Informal Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
研究概览
简要总结
The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also determining it's cost effectiveness in the stroke and traumatic brain injury (TBI) populations.
详细描述
Background: Stroke and traumatic brain injury (TBI) are leading causes of long-term disability among Veterans and result in the need for care from informal caregivers in the home setting. There are very few evidence-based, easy-to-deliver follow-up programs to train Veterans and caregivers across multiple domains post injury. The "Acquiring New Skills While Enhancing Remaining Strengths for Veterans (ANSWERS-VA)" intervention aims to provide the Veteran and caregiver dyad with a set of practical skills that each can use in coping with and managing symptoms of a brain injury, applying a strength-based approach.
Objectives: The objectives of this study are to conduct a randomized controlled trial (RCT) to evaluate (a) the efficacy of the ANSWERS-VA dyadic intervention with Veterans who have sustained a stroke and/or TBI and their informal caregivers, and (b) estimate effect sizes for the ANSWERS-VA intervention. The ANSWERS-VA intervention will be compared with an educational intervention that will serve as an attention control group.
Specific Aim 1: To tailor the implementation of the ANSWERS-VA intervention to dyads of Veterans post stroke and/or TBI and their informal caregivers (n=10) and modify the implementation processes for the RCT.
Specific Aim 2: To test the short-term (immediately post-intervention) and long-term, sustained (12 and 24 weeks, and at 1 year) efficacy of the ANSWERS-VA intervention for improving: (a) the primary outcomes of the caregivers' quality of life and unhealthy days, and (b) the caregiver mediators of task difficulty, threat appraisal, self-efficacy for caregiving, and optimism.
Specific Aim 3: To evaluate program delivery costs for the ANSWERS-VA intervention and the educational attention control procedures, and to assess the cost-effectiveness of the ANSWERS-VA intervention in terms of noncaregiving hours and unhealthy days in caregivers of Veterans post stroke and/or TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informal caregiver of a family member or friend (Veteran) with a stroke or TBI
- •Caregiver must express need or concerns in providing care
- •Plans to be providing care for 1 year or longer
- •Access to telephone
- •Willingness to participate in 9 call from a nurse and 5 data collection calls at designated timepoints
- •Veteran's stroke must be within past 3 years
- •Veteran's TBI must be since 9/11/01
排除标准
- •Caregiver or survivor age < 18 years
- •Caregiver denies that survivor has had a stroke or a TBI
- •Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke or TBI
- •Caregiver has low task difficulty (OCBS task difficulty score < 16)
- •Caregiver communication difficulties (e.g., hearing loss)
- •Caregiver not fluent in the English language
- •Caregiver with serious medical illness limiting ability to participate
- •Caregiver refuses to sign a HIPAA authorization allowing the VA to store personal health information (PHI) in a location outside the VA
- •Survivor residing in a nursing home or long-term care facility
- •Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
- •Survivor or caregiver history of hospitalization for alcohol or drug abuse
- •Survivor or caregiver history of Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, or schizophrenia.
- •Survivor or caregiver pregnancy
- •Survivor or caregiver is a prisoner or on house arrest
- •Survivor had a Transient Ischemic Attack (rather than a hemorrhagic or ischemic stroke)
- •Survivor had a stroke more than 3 years ago
结局指标
主要结局
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
时间窗: Baseline, Week 12, 6 months and 1 year
Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression.
Mediators of Caregiver's Threat Appraisal Scale
时间窗: Baseline, Week 12, 6 months and 1 year
Threat appraisal is measured with the Appraisal of Caregiving Scale: Threat Subscale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating less belief, feelings and ability to take care of a loved one with stroke or brain injury in the future.
Mediators of Caregiver's Task Difficulty
时间窗: Baseline, Week 12, 6 months and 1 year
Task difficulty is measured with the Oberst Caregiving Burden Scale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating higher levels of burden.
Mediators of Caregiver's Optimism Scale
时间窗: Baseline, Week 12, 6 months and 1 year
Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism.
次要结局
未报告次要终点